The role and impact of patient-based health status measures on clinical decision making and clinician-patient communication in routine clinical practice

There is a growing consensus about the importance of estimating clinically meaningful differences and methods of estimation. This session provides an example of an application to a newly developed measure of mucositis to help with interpretation of clinical trial data. Also discussed are important caveats about the determination of a clinically meaningful difference. CONCLUSIONS: This session provides guidance on applying what is currently known about estimating the clinically meaningful difference of PRO measures. It is concluded that no single approach is adequate by itself, and multiple methods of estimation are necessary to provide bounded estimates of the important difference. DISCLOSURES: The drug discussed in this presentation has not yet been approved for marketing. Dr. Hays is a consultant to Amgen, Inc., and Pfizer Inc.